Catalog Number

47625

Brand Name

Halyard

Version/Model Number

47625

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

12ee4c4c-18f8-48ff-be8e-3af1f49d484a

Public Version Date

September 02, 2022

Public Version Number

6

DI Record Publish Date

March 17, 2016

Package DI Number

30680651476259

Quantity per Package

6

Contains DI Package

20680651476252

Package Discontinue Date

September 01, 2022

Package Status

Not in Commercial Distribution

Package Type

CS